On June 24, CMS released a change request informing contractors of new CLIA waived tests approved by the Food and Drug Administration. Since these tests are marketed immediately after approval, CMS must notify its contractors of the new tests so that the contractors can accurately process claims. There are 30 newly added waived complexity tests. This recurring update notification applies to Chapter 16, Medicare Claims Processing Manual, section 70.8 of the IOM.
Your Medicare Administrative contractor (MAC) will not search their files to either retract payment or retroactively pay claims; however, they should adjust such claims brought to their attention.
The following tests are approved by the FDA as waived tests under CLIA (QW Modifier required):
| CPT Code | Effective Date | Description | |
| G0434QW | from August 21, 2015 to December 31, 2015 | Healgen Scientific LLC, Healgen Multi-Drug Urine Test Dip Card | |
| G0477QW | on and after January 1, 2016 | Healgen Scientific LLC, Healgen Multi-Drug Urine Test Dip Card | |
| G0477QW | March 8, 2016 | Tanner Scientific Multi-Panel Drug Test Cup | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Easy Cup | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Split Key Cup | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Test Cassette | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Marijuana Test Dip Card | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Easy Cup | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Split Key Cup | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Test Cassette | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Metamphetamine Test Dip Card | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Easy Cup | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Split Key Cup | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Test Cassette | |
| G0477QW | March 18, 2016 | Hangzhou Clongene Biotech Co., Ltd. Clungene Morphine Test Dip Card | |
| 87338QW | March 22, 2016 | Meridian Bioscience Immunocard STAT! HpSA (Stool) | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Amphetamine Dip Card | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Amphetamine Quick Cup | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Amphetamine Strip | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Amphetamine Turn-Key Split Cup | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Cocaine Dip Card | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Cocaine Quick Cup | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Cocaine Strip | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Cocaine Turn-Key Split Cup | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Morphine Dip Card | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Morphine Quick Cup | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Morphine Strip | |
| G0477QW | March 31, 2016 | Assure Tech Co., Ltd. AssureTech Morphine Turn-Key Split Cup | |
| G0477QW | April 21, 2016 | Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Cup Tests | |
| G0477QW | April 21, 2016 | Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Cup | |
Effective date: October 1, 2016
Implementation date: October 3, 2016
View the Transmittal here: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3563CP.pdf